SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container
- Name:
SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container
- Company:
Santen UK Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/12/20

XPIL
Package leaflet: Information for the patient
Package leaflet: Information for the patient
1. What SAFLUTAN is and what it is used for
1. What SAFLUTAN is and what it is used for
2. What you need to know before you use SAFLUTAN
2. What you need to know before you use SAFLUTAN
3. How to use SAFLUTAN
3. How to use SAFLUTAN
4. Possible side effects
4. Possible side effects
5. How to store SAFLUTAN
5. How to store SAFLUTAN
6. Contents of the pack and other information
6. Contents of the pack and other information
Click on this link to Download PDF directly
Santen UK Limited

Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 14 December 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2
SAFLUTAN contains phosphates
This medicine contains approximately 0.04 mg phosphates in each drop which is equivalent to 1.2 mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
Section 4
Effects on the respiratory system:
- worsening of asthma, shortness of breath
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971; Fax: +353 1 6762517, Website: www.hpra.ie; e-mail: medsafety@hpra.ie
Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal
The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D'Argens, GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt, e-mail: postlicensing.medicinesauthority@gov.mt
section 6
This leaflet was last revised December 2020March 2020
Updated on 14 December 2020 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2
One ml of eye drops, solution, contains 15 micrograms of tafluprost.
One single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost.
One drop (about 30 microl) contains about 0.45 micrograms of tafluprost.µ
Excipient with known effect: One ml of eye drops solution contains 1.2 mg phosphates and one drop contains approximately 0.04 mg phosphates.
For the full list of excipients, see section 6.1.
Section 4.8
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, website: www.hpra.ie.Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Section 10.
10 December 2020November 2017
Updated on 24 March 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 6 - Contents of the pack and other information
....
Manufacturer
Santen Oy
, Niittyhaankatu 20 FI-33720
Kelloportinkatu 1, 33100
Tampere
Finland
This leaflet was last revised March 2020
Updated on 11 December 2017 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
…
There is a potential for hair growth to occur in areas where tafluprost solution comes repeatedly in contact with the skin surface.
…
4.8 Undesirable effects
…
Eye disorders
…
Not known (cannot be estimated from the available data): iritis/uveitis, lid sulcus deepened, macular oedema/cystoid macular oedema.
…
10 DATE OF REVISION OF THE TEXT
July 2015
November 2017
Updated on 11 December 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 7 December 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 7 December 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 4 January 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 4 January 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)